NITROFURANTOIN MACROCRYSTALS capsule

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

NITROFURANTOIN (UNII: 927AH8112L) (NITROFURANTOIN - UNII:927AH8112L)

Dostopno od:

Alvogen Inc.

INN (mednarodno ime):

NITROFURANTOIN

Sestava:

NITROFURANTOIN 25 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Nitrofurantoin macrocrystals capsules is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus , and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin macrocrystals capsules and other antibacterial drugs, nitrofurantoin macrocrystals capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic

Povzetek izdelek:

Nitrofurantoin macrocrystals capsules is available as follows: 25 mg opaque, white capsule imprinted with “MACRODANTIN 25 mg” and “52427-286”. NDC 47781-306-01 bottle of 100 50 mg opaque, yellow and white capsule imprinted with “MACRODANTIN 50 mg” and “52427-287”. NDC 47781-307-01 bottle of 100 100 mg opaque, yellow capsule imprinted with “MACRODANTIN 100 mg” and “52427-288”. NDC 47781-308-01 bottle of 100 Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Status dovoljenje:

New Drug Application

Lastnosti izdelka

NITROFURANTOIN MACROCRYSTALS- NITROFURANTOIN MACROCRYSTALS CAPSULE
ALVOGEN INC.
----------
NITROFURANTOIN MACROCRYSTALS CAPSULES
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of nitrofurantoin
macrocrystals capsules and other antibacterial drugs, nitrofurantoin
macrocrystals capsules should be
used only to treat or prevent infections that are proven or strongly
suspected to be caused by bacteria.
DESCRIPTION
Nitrofurantoin macrocrystals capsules is a synthetic chemical of
controlled crystal size. It is a stable,
yellow, crystalline compound. Nitrofurantoin macrocrystals capsules is
an antibacterial agent for
specific urinary tract infections. It is available in 25 mg, 50 mg,
and 100 mg capsules for oral
administration.
1-[[(5-nitro-2-furanyl)methylene] amino]-2,4-imidazolidinedione
INACTIVE INGREDIENTS: Each capsule contains edible black ink, gelatin,
lactose, starch, talc, titanium
dioxide, and may contain FD&C Yellow No. 6 and D&C Yellow No. 10.
CLINICAL PHARMACOLOGY
Nitrofurantoin macrocrystals capsules is a larger crystal form of
nitrofurantoin. The absorption of
nitrofurantoin macrocrystals capsules is slower and its excretion
somewhat less when compared to
nitrofurantoin. Blood concentrations at therapeutic dosage are usually
low. It is highly soluble in urine,
to which it may impart a brown color.
Following a dose regimen of 100 mg q.i.d. for 7 days, average urinary
drug recoveries (0 to 24 hours)
on day 1 and day 7 were 37.9% and 35.0%.
Unlike many drugs, the presence of food or agents delaying gastric
emptying can increase the
bioavailability of nitrofurantoin macrocrystals capsules, presumably
by allowing better dissolution in
gastric juices.
MICROBIOLOGY
Nitrofurantoin is a nitrofuran antimicrobial agent with activity
against certain Gram-positive and Gram-
negative bacteria.
MECHANISM OF ACTION
The mechanism of the antimicrobial action of nitrofurantoin is unusual
among antibacterials.
Nitrofurantoin is reduced by bacterial flavoproteins to reactive
intermediates